pump pressure conveying quantity chamber geometry flow conditions Washing arms trays water quantity dosing temperature foam performance

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1 Validation of cleaning and disinfecting processes in WDs: Implementation of the ÖGSV- Guideline M. Gehrer, T. Miorini, V. Buchrieser, A. Gruber, G. Maierl

2 Processing of instruments preferably automated thermal processes Washer-disinfector Within the procurement of new instruments suitability for an automated process should be a determining criterion 2

3 Automated cleaning and disinfection Cleaning efficacy depends on: kind of MD kind of contamination professional loading (right position, no overloading, no obstruction of the moving parts etc.) correct service (e.g. cleaning of nozzle and sieves) cleaning process in WD (mechanics, chemicals, time, temperature)

4 Influencing factors cleaning efficacy detergents dosing water quality dosing temperature foam performance pump pressure conveying quantity chamber geometry flow conditions Washing arms trays water quantity dosing temperature foam performance heating up cleaning last rinse Pre rinse Cleaning Last rinse 4

5 ÖNORM EN ISO Part 1-5 Washer-Disinfectors Part 1: General requirements, definitions and tests Part 2: Requirements and tests for washer-disinfectors employing thermal disinfection for surgical instruments, anaesthetic equipment, hollowware, utensils, glassware etc. Part 3: Requirements and tests for washer-disinfectors employing thermal disinfection for human waste container 5

6 ÖNORM EN ISO Part 1-5 Washer-Disinfectors Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermo-labile endoscopes Part 5: CEN ISO/TS : Test soils and methods für demonstrating cleaning efficacy 6

7 Validation Documented procedure for obtaining, recording and interpreting data required to show, that a process will comply consistently with predetermined specifications Validation should confirm the conformity of the processes in the WD with the given specifications as well as the qualification of the process for the MDs used on site ÖNORM EN 15883: Validation = entire programme, consisting of Installation qualification (IQ), Operation qualification (OQ) and Performance qualification (PQ) 7

8 Validierung Validation of reprocessing is the verification of the process being suitable for defined products in defined packages and load configurations to meet the intended efficacy reproducible under the conditions on site (i.e. is able to bear clean, disinfected and - if applicable - sterile products) 8

9 ÖGSV-guideline to validation describes principles for validation, revalidation and routine control of reprocessing in WDs meeting the standard also applicable to non-conform WDs Text of guideline Annex 1: Test method und contents Annex 2: Report Part 1: Commissioning protocol Part 2: Test protocol for OQ and PQ Annex 3: Procurement 9

10 Preconditions for validation structural requirements qualification of staff adequate quality assurance/quality management risk evaluation and classification of MD and MD-groups technical minimum requirements for WDs supply of resources (e.g. demin. water) 10

11 Operative Preconditions organisation chart information of the WD manufacturer (e.g. calibration protocols, program specifications) instruction manual for the WD instructions of the MD manufacturer for reprocessing information of the manufacturer of the process chemicals load configurations standard instructions for all steps of reprocessing risk classification according RKI operation journal hygiene plan (incl. Cleaning/disinfection-plan) maintenance plan routine control plan evidence of qualification resp. education Criteria for product release and -documentation 11

12 Minimum requirements for WD Automatic cycle (freely programmable programmes) Adjustable temperature display Automatic dosing of chemicals permanent fault indication Cycle counter (or documented control system) Process documentation (minimum: temperature / time parameters as actual values, date, time) suitable load carriers for MIS instruments, anesthetic equipment, if applicable 12

13 Prüfung/Validierung Type test / Works test Installation Qualification (IQ) VALIDATION Operation Qualification (OQ) Validation in the more specific sense Commissioning technical inspection hygienic inspection (Assessment of structural. technical preconditions (if applicable: repetition of specific tests of OQ) Performance Qualification Routine control and annual revalidation (re-qualification) 13

14 V a l i d a t i o n Installationsprüfung Betriebsprüfung (technische Abnahmeprüfung, hygienische Abnahmeprüfung) Kommissionierung (Kontrolle der Rahmenbedingungen, ggf. Nachholung der Betriebsprüfung) Leistungsprüfung ja RDG nach pren ISO negativ nein Mindestanforderungen erfüllt? (siehe 5.3) ja nicht gesetzeskonform! bis zur Validierung jährliche Hygieneprüfung (Reinigungs- /Desinfektionswirkung) nein Gerät austauschen oder nachrüsten! jährliche Revalidierung (erneute Leistungsprüfung) 14

15 Type test/ Works test (Manufacturer) Type test: Sequence of tests to determine process parameters for a certain type of WD Works test: Sequence of tests, carried out on a single WD at the manufacturing site to provide evidence of the accordance with it s specification 15

16 IQ / OQ Installation Qualification (responsibility of the manufacturer) Inspection, if the WD was delivered, installed and supplied with resources according to the contract and the device is safe for operation Operation Qualification (responsibility of the manufacturer) technical inspection (evtl. in combination with IQ) hygienic inspection 16

17 OQ: Technical Inspection Checking of: documentation doors and interlocks recources supply safety features and equipment (e.g. doors and interlocks) construction (finish) (e.g. welded seams) display and recording instrumentation (calibration) if applicable: further technical specifications (e.g. in accordance with tendering) 17

18 Hygienic Inspection In responsibility of the manufacturer preferably independent hygiene expert in case of positive result of IQ and OQ the preconditions for taking-over of the device by the institution is given For problems during PQ due to MDs or load configuration used on site the manufacturer is out of responsibility, unless there exist other contract details Prüfanschmutzung Schafblut 18

19 OQ: Hygienic Inspection- Austrian Test Method (CEN ISO/TS ) Cleaning efficacy (standard soiling) Chamber (KMNE) load carrier (KMNE) load (3x) (MNE, reactivated sheep blood) Disinfection efficacy, temperature control, reproducibility (thermoelectric) chamber walls load carriers load Accuracy of display/recording dosing accuracy water quality softened water deionised water last rinse water chemical/physical ph, conductivity, hardness, Chlorine (bacteriological) 19

20 Test method surgical instruments Test soil: reactivated sheep blood application of TS with brush critical spots (joints) Drying app. 2 x 30 min (upside down) Interruption after Cleaning! Repetition 3 x 20

21 Evaluation surgical instruments Evaluation Visual check Protein detection (if necessary) Criteria for acceptance Max. 5 % of soiled instruments may show residual soiling Protein detection: within acceptance criteria (20 µg/ Instrument) 21

22 Validation Commissioning: technical, operational and organisational preconditions as well as documentation is checked Performance Qualification: the process is checked for ist efficacy and reproducibility, that means... 22

23 Performance qualification Cleaning efficacy is tested under real conditions with: the MD to be reprocessed the specified load configurations (preferably worst case) the specified program sequence the available resources the chosen detergents evaluation by protein detection tests limit: 20 µg/instrument 23

24 Practicability of the Austrian test method Easy to accomplish Soiling on-site Analysis (visual control) possible without further effort Faults/deficiencies/problems (e.g. dosing of detergents, insufficient water quantity etc.) can be detected and solved followed by a control survey 24

25 Problems in practice chamber geometry washing arms (construction/ velocity) pump pressure (foam performance) water quantity load carrier (condition of water flow) trays detergents (high-/low-alkaline/ neutral) foam performance dosing temperature dosing quantity dosing pumps (-tubes) water quality 25

26 Summary -1 The evaluation of the Austrian test method for WD-testing (especially for surgical instruments) showed, that it is suitable for an adequate process assessment. The averaged results are confident indicators for the efficacy of the tested cleaning process 26

27 Summary - 2 Compliance with the 5% limit guarantees satisfying cleaning results during routine operation Protein detection tests on instruments with real contamination show consistently results below the defined acceptance criteria of 20 µg/instrument Good repeatability 27

28 Reproducibility of the Test Method relative Summenhäufigkeit in % Binomialverteilung Obergrenze (95 %) Untergrenz (95 %) empirische Σ Werte Instrumente m it Restverschmutzung (Gesamtzahl 120) 28

29 Summary - 3 The implementation of new test methods (e.g. the new Austrian one) is an important part of the quality improvement in the field of reprocessing of medical devices and is finally able to help raising patient safety. 29

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